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RECRUITING
NCT06818136

Bladder EpiCheck European Haematuria Study

Sponsor: Nucleix Ltd.

View on ClinicalTrials.gov

Summary

The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed. Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.

Official title: Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2025-06-20

Completion Date

2026-12

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Bladder EpiCheck

The participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change.

Locations (5)

NHS Fife

Dunfermline, Fife, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

NHS Lothian

Edinburgh, United Kingdom

Guy's and St Thomas

London, United Kingdom

Frimley

Surrey Quays, United Kingdom